Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients

Chronic Pain Clinical Trial

Official title:

Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618002
• Other study ID #: SalemAnaesth2022 LemborexZop
• Status: Recruiting
• Start date: November 8, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Salem Anaesthesia Pain Clinic
• Contact: Olu Bamgbade, MD,FRCPC
• Phone: +17786286600
• Email: salem.painclinic[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective observational crossover study of 150 consenting adult patients who are undergoing chronic pain management. For insomnia treatment, each patient ingests prescribed doses of Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data including pain score, sleep score, sleep duration, sleep medication type, and adverse effects. Each patient completes the diary for 3 continuous weeks. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant.

Description:

Objectives: Chronic pain is usually associated with insomnia. The objective of this clinical study is to compare the safety and efficacy of Lemborexant or Zopiclone or Clonidine; for the management of chronic insomnia in patients with chronic pain. Methods: Prospective observational crossover study of 150 consenting adult patients who are undergoing chronic pain management. For insomnia treatment, each patient ingests prescribed doses of Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data including pain score, sleep score, sleep duration, sleep medication type, and adverse effects. Each patient completes the diary for 3 continuous weeks. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant. Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• adult chronic pain patients
• good treatment compliance
• severe chronic insomnia
• failure of non-pharmacologic sleep therapy
• regular zopiclone therapy for 3 months or more
• regular sleep diary
• regular pain diary
• informed consent for diary review
• consent for clinical record quality assurance review

Exclusion Criteria:

• obstructive sleep apnoea
• body mass index (BMI) =40
• organ insufficiency
• cognitive disorder
• inability to provide consent
• major neuropsychiatric disorder
• unreliable diary
• cannabis use
• regular alcohol intake
• stimulant use
• substance abuse
• poor treatment compliance
• high dose opioid
• gabapentinoid use
• sedative use
• mild insomina
• irregular zopiclone intake
• regular zopiclone therapy for less than 3 months
• previous adverse/allergic reactions to clonidine or zopiclone

Related Conditions & MeSH terms

• Chronic Insomnia
• Chronic Pain
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Lemborexant
For insomnia treatment, each patient ingests Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data.

Locations

Country	Name	City	State
Canada	Salem Anaesthesia Pain Clinic	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Salem Anaesthesia Pain Clinic

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Bamgbade OA, Tai-Osagbemi J, Bamgbade DO, Murphy-Akpieyi O, Fadire A, Soni NK, Mumporeze L. Clonidine is better than zopiclone for insomnia treatment in chronic pain patients. J Clin Sleep Med. 2022 Jun 1;18(6):1565-1571. doi: 10.5664/jcsm.9930. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep quality score, objective measurement using the validated Likert sleep scale	Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep	3 weeks
Secondary	Pain score, objective measurement using the validated Numeric Pain Rating scale	Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain	3 weeks